Manufacturing quality evaluation is a critical discipline that focuses on assessing a process’s ability to produce outputs within pre‐defined tolerance limits. Recent advances combine traditional ...

This study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning. Pharmaceutical development ...

The author argues that traditional concerns about repeatability and intermediate precision remain valid but insufficient. The US Pharmacopeia is replacing its current Chapter <111> "Design and ...

Boeing’s processes for ensuring its aircraft are consistently built to company specifications are undergoing a major revamp—due in large part to lessons learned from 787 production-quality problems ...